Senior Manufacturing Engineer

1 month ago

Pompano Beach, United States Medical Device Manufacturing Co Full time
Job DescriptionJob Description

Applies aspects of subject matter expert knowledge and experience in the identified discipline of engineering. Senior-level position responsible for proactively recommending solutions and projects to management within departmental objectives. Capable of leading a project team and supervising other engineers and technicians. Provides input to budget and resource allocation without direct hire/fire responsibility. Measured against performance plan goals and objectives. Responsible for functional performance when applicable.

 

Essential Duties and Responsibilities:

· Participate in the design, development, implementation, and maintenance of tools, dies, molds, jigs, and fixtures for manufacturing processes.

· Work closely with production and product development teams to ensure that the tooling is efficient, cost-effective, and meets quality standards.

· Provide technical expertise and manufacturing support to the injection molding department (IMO) in the evaluation of proposed medical device designs for manufacturability.

· Assist in the development of capital equipment budget including but not limited to injection molding machines, molds, and accessory equipment to support long term growth.

· Provide technical advice related to plastic component material selection and part design to achieve required cost, performance, and quality requirements for new products as defined per the Product Development roadmap.

· Quote, select, develop, and inspect (FAI) molds for injection molding.

· Responsible for scheduling all injection molding repairs to ensure lead times are achieved.

· Recommend materials for tool production based on durability, cost, and function.

· Maintain injection molding tools and equipment in a required state of readiness as defined by management to meet the requirements of Product Development, Manufacturing, Quality Assurance and Regulatory.

· Participate in R&D product development, supplier selection and development activities.

· Evaluate and interpret engineering drawings and specifications.

· Train tool room staff on correct use of tooling equipment and safety procedures.

· Coordinate with tool manufacturers and vendors for tool procurement.

· Provide direction and guidance on maintenance and repair activities on tools to ensure longevity and functionality.

· Support APO equipment troubleshooting, and repairs as requested.

· Comply with policies, regulations and values for safety, quality, environmental and financial standards.

· Performs other duties as required.

 

Required Job Qualifications:

· Minimum 7 years of proven experience in tooling for manufacturing environment in injection molding.

· Clear understanding of injection molding processing.

· Extensive experience in tooling design and troubleshooting.

· Experience in communicating with vendors, purchasing new equipment and injection molds.

· Minimum of 5 years related experience in an FDA/GMP regulated injection molding facility.

· Experience with measuring devices such as calipers, drop gauges, gauge blocks/pins, and comparators.

· Computer skills with MS-Office.

· Basic knowledge of Computer Aided Design Tools: AutoCAD and SolidWorks.

 

Preferred Job Qualifications:

· Experience providing training related to injection molding.

· Six Sigma or Lean Six Sigma green/yellow belt.

· Extensive knowledge of the ISO/FDA requirements for medical devices.

· Bachelor’s degree in an Engineering or Science discipline or equivalent work experience.

 

Physical Demands:

· Performs primarily office activities in a lighted and ventilated area. May be subject to changes in temperature and exposure to dust.

· Physical activity includes walking, standing, bending, squatting, reaching above shoulders and lifting up to 40 lbs.

· Must be able to drive an automobile for short and long distances.

· Use good judgement and follow procedures.

· Work under stress in a fast-paced environment

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